The following prior art publications are considered to be relevant for an understanding of the prior art:
U.S. Pat. No. 6,293,923.
Coletti et al Cytometry Part A, 71A:846-856, 2007.
Report of the UN Secretary-General. 69th Session of the General Assembly, Aug. 5, 2014—A/69/256: Supporting efforts to end obstetric fistula.
US Patent Application 2005/0131,442.
Involuntary urine leakage from the bladder can result from various causes which can be generally divided into two groups:
Anatomical causes such as destruction or under-functioning of the urethral sphincteric mechanism or development of a vesicovaginal, vesicouterinal or ureterovaginal fistula. Sensorial causes include reduction in the functional capacity of the bladder creating an uncontrollable urge to void that may induce uncontrollable urination.
Several surgical and non-surgical methods, such as urethral slings for preventing urethral descent in severe stress urinary incontinence (SUI) cases, and various vaginal pessaries for urethral compression for lighter cases, have been developed.
The gastroesophageal sphincter is a muscular entity sealing the esophagus from the stomach. Normally, the sphincter opens during swallowing, allowing food to enter into the stomach. The rest of the time, it closes tightly to prevent food and acid in the stomach from backing up into the esophagus.
Gastroesophageal reflux disease (GERD) is a digestive disorder in which the gastroesophageal sphincter does not seal tightly, and remains relaxed between swallows. This allows gastric contents, including acidic digestive juices, to enter the esophagus and irritate the esophagus. If GERD is not treated, it can permanently damage the esophagus or even lead to the development of a cancerous growth at the esophagus. Many things can weaken or loosen the lower esophageal sphincter including certain foods, smoking, alcohol, many medications, increased abdominal pressure due to of obesity or pregnancy, and a weakening of the diagraphragmatic muscle causing part of the stomach to bulge and protrude above the diaphragm (hiatal hernia) and disrupt the functioning of the sphincter.
The term “vesicovaginal fistula” refers to the presence of a fistula or passageway between the urinary bladder and the vagina and it is the most common urogenital fistula. This causes constant leakage of urine form the bladder into the vagina and out from the vagina and results in frequent vaginal and vulvar irritation and bladder infections. Vesicovaginal fistulae require surgical repair by experienced surgeons. In the developed world, such fistulas are uncommon and usually result from complications of gynecological surgery, pelvic abscess or pelvic irradiation. In poor developing countries however, these fistulas are more common and are related to obstructed labor due to unattended deliveries, small pelvic dimensions, malpresentation, poor uterine contractions and introital stenosis, especially in very young girls. In some parts of Africa, it is estimated that in as many as 3-4 per 1000 vaginal deliveries women develop these fistulas. A 2014 report of the United Nations Secretary-General states: “Obstetric fistula is a devastating childbirth injury that leaves women incontinent and often stigmatized and isolated from their families and communities.” “The odour from constant leakage, combined with misperceptions about its cause, often results in stigma and ostracism. Many women with fistula are abandoned by their husbands and families. They may find it difficult to secure income or support, thereby deepening their poverty.” (Report of the UN Secretary-General. 69th Session of the General Assembly. Aug. 5, 2014—A/69/256: Supporting efforts to end obstetrric fistula) Non-surgical therapy for vesicovaginal fistulas is rarely effective; and most vesicovaginal fistulas require surgery by experts to close the opening usually through the abdomen or vagina. In certain cases it can be treated with laparoscopic or robotic surgery.
Conservative treatments for mild SUI are based on pelvic floor musculature reinforcement either by electrical stimulation or by other physiotherapeutic means such as Kegel exercises, approaches that need close and active cooperation of the patients.
Although severe SUI and pelvic floor descensus cases can be successfully treated with surgery based on implantation of natural fascial slings or artificial mesh slings, in about 30-40% of SUI cases the incontinence recurs within 5-10 years mostly due to age-related hormonal deficiency causing weakening of the pelvic floor muscle.
Extracorporeal magnetic stimulation created by pulsating magnetic fields or a single magnetic field has been shown to induce muscle tissue formation in tissue cultures (Coletti et al. Cytometry Part A, 71A:846-856, 2007).